Skip to main content
OpenTrials
Completed

NCT Number: NCT06109987

Clinical Evaluation of Bulk-fill Restorative Materials

High-viscosity glass ionomer cements have been developed to improve the weak mechanical properties of glass ionomer cements, increase wear resistance and improve their limited indications. There are limited clinical studies on the use of high-viscosity glass ionomer cements in areas with large cavities bearing stress. The aim of this study is to compare the clinical performance of two different high-viscosity glass ionomer cements with a bulk-fill resin composite in different cavities.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muhammet Karadaş

Rize, Merkez, 53100, Turkey (Türkiye)

About this study

This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in Class I, II, and V restorations.

The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of marginal discoloration, fracture and retention, marginal adaptation, post-operative sensitivity, secondary caries, color match and difference criteria were examined.

Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries.

Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p < 0.05).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily agreed to participate in the study after being informed about the study.
  • Volunteer must not be under 18 years of age
  • No systemic disease
  • Having healthy oral hygiene
  • As a result of clinical and radiographic examination, there is a carious lesion at D1 and D2 levels according to the caries classification method.
  • The tooth to be restored is vital

Exclusion criteria

  • Refusal to participate in the study after being informed about the study
  • The patient has a history of teeth grinding
  • Volunteer must be under 18 years of age
  • The volunteer is undergoing or will begin orthodontic treatment
  • The volunteer has a serious systemic disease
  • The tooth to be restored has endodontic and periodontal problems
  • Volunteer's pregnancy status
  • Extraction of one of the teeth opposite or in contact with the tooth to be restored

Treatment and study plan

World Dental Federation criteria (FDI)

Other

Restorations were evaluated with FDI criteria.

Primary outcomes

  1. Evaluation of different restorative materials

    Time frame: Baseline

    Restored teeth were evaluated according to FDI criteria.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Clinical Evaluation of High-viscosity Glass-hybrid Systems Compared With a Bulk Fill Composite Resin in Different Cavity Type

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 31, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.